Abstract
Background: It is estimated that 225 million women worldwide have an unmet need for family planning, and more than half live in low- and middle-income countries. Increasing the choice of contraceptive methods available can reduce this unmet need. Microneedle drug delivery systems represent a new technology for minimally invasive self-administration of contraceptives. We explored stakeholders’ views on different aspects of a proposed microneedle-based hormonal contraceptive delivery system. The feedback was used to iteratively develop this delivery system. Methods: Focus group discussions and semi-structured interviews were conducted with potential stakeholders (women and trans males of childbearing age, their partners, and health professionals and organisations that provide family planning advice and contraception services) in Uganda, The Gambia, Malawi, and the UK, exploring concept acceptability and gathering feedback on different aspects of design and usability of the proposed delivery system. Results: Participants viewed the concept of a new, microneedle-based contraceptive favourably. In Uganda, participants were presented with 7 different prototype applicators and identified desirable features of a preferred delivery device; their input reducing the number of prototypes that were subsequently evaluated by stakeholders in The Gambia and the UK. Participants in these countries helped to identify and/or confirm the most desirable characteristics of the applicator, resulting in design consolidation into a refined concept applicator. The final, optimised applicator prototype was validated during user research in Malawi. This human-centred design approach was also used to iteratively develop an information leaflet for the device. During these user studies, other preferred aspects of a contraceptive delivery system were also evaluated, such as anatomical site of application, duration of action, and return to fertility. Conclusions: A new microneedle-based contraceptive delivery system was iteratively developed using a human-centred design approach and was favourably received by potential stakeholders. The product is now being refined for testing in pre-clinical studies.
Highlights
The United Nations (UN) Sustainable Development Goals for 2030 recognise the importance of Family Planning (FP) as a key component of global good health and wellbeing (Goal 3.7)[1]
In this study, the Human-centred design (HCD) approach used to develop a new MN-based progestin-only hormonal contraceptive delivery system targeted at women who have an unmet need for contraception is described
We anticipate that the involvement of the intended end users and other stakeholders during all phases of product development has facilitated the design of a product that is more likely to be accepted and adopted in low- and middleincome countries (LMICs)
Summary
The United Nations (UN) Sustainable Development Goals for 2030 recognise the importance of Family Planning (FP) as a key component of global good health and wellbeing (Goal 3.7)[1]. Despite a worldwide increase in contraception use, it is estimated that currently 225 million women worldwide have an unmet need for FP (to limit or space births). Increasing the number and variety of methods of contraception available to potential end-users has been proposed as a strategy to help reduce the unmet need for FP in these countries[12,19]. We explored stakeholders’ views on different aspects of a proposed microneedle-based hormonal contraceptive delivery system. Methods: Focus group discussions and semi-structured interviews were conducted with potential stakeholders (women and trans males of childbearing age, their partners, and health professionals and organisations that provide family planning advice and contraception services) in Uganda, The Gambia, Malawi, and the UK, exploring concept acceptability and gathering feedback on different aspects of design and usability of the proposed delivery system. In Uganda, participants were presented with 7 different prototype applicators and identified desirable features of a preferred delivery device; their input reducing the number of prototypes that were subsequently evaluated by stakeholders in The version 3
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